MAUDE Adverse Event Report: UNKNOWN MCKESSON BRANDS; SYRINGE, LL 10CC

Catalog Number	16-S10C
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that when they attempted to fill the syringe with medication, there appeared to be some black-like plastic or particle in the syringe.No information was received regarding any serious injury as a result of this product issue.
Additional Manufacturer Narrative
This syringe is sourced from more than one manufacturer.The customer could not provide a lot number allowing for identification of the manufacturer.

• Brand Name: MCKESSON BRANDS
• Common Device Name: SYRINGE, LL 10CC
• Manufacturer (Section D): UNKNOWN; CH
• MDR Report Key: 19600330
• Report Number: 1451040-2024-00029
• Device Sequence Number: 6359290
• Product Code: FMF
• UDI-Device Identifier: 10612479206882
• UDI-Public: 10612479206882
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2024
• Report Date (Section F): 06/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 16-S10C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/29/2024
• Device Age: 12 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/24/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/24/2024